Biocyl plaque extractor

ABSTRACT

An improved plaque extractor for shaving, scooping, cutting, and emulsifying accumulated plaque from blood vessels into fine particles, and removing the particles from blood vessel walls without cutting or permanently stretching the walls, and without substantially blocking the blood flow through the vessel during plaque removal operation. The plaque extractor includes an extractor guide and an internal auger, in which both are rotating and moving axially inside the vessel to engage the occlusive material. The operation of the device does not substantially disrupt blood pressure within the blood vessel.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of and priority to U.S. patentapplication Ser. No. 17/826,210, filed on May 27, 2022, the contents ofwhich are incorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to an improved blood vessel plaque extractor forshaving, scooping, cutting, and emulsifying accumulated plaque fromblood vessel walls into small particles, without cutting or permanentlystretching the walls, and without substantially blocking the blood flowthrough the vessel during plaque removal operation.

BACKGROUND OF INVENTION

Atherosclerosis is a form of arteriosclerosis in which plaqueaccumulates in an arterial vessel and the artery wall thickens as aresult of invasion and accumulation of white blood cells on the innerartery vessel walls. These plaque accumulations contain both living,active WBCs (producing inflammation) and remnants of dead cells,including cholesterol and triglycerides. The remnants eventually includecalcium and other crystallized materials, to form plaque. The plaquereduces the elasticity of the artery vessel walls. It is commonlyreferred to as a “hardening” or furring of the arteries.

Over time these plaques can become large enough to reduce or occludeblood flow through the vessels, leading to symptoms of low blood flow.To treat this disease blood flow must be restored through the vessel, byremoving or reducing the size of these plaques.

Various types of plaque removal devices and techniques have been used toremove unwanted plaque from blood vessels to open the vessel and improveblood flow. For example, atherectomy catheters and devices areintravascular devices that mechanically remove plaque from the arteryvessel walls.

However, atherectomy catheters and devices often undesirably cut,perforate, tear and stretch the vessel, causing scar formation. Suchscar tissue causes inflammation, stenosis and blocks flow in the vesseland often needs to be removed. Furthermore, atherectomy catheters oftenrun at high speeds causing temperature and causing damage to thevessels. Finally, atherectomy catheters block arterial blood flowcompletely during plaque removal, resulting in high vessel bloodpressure, and posing a danger to the patient.

It is therefore desirable to provide an improved device and method forremoving plaque from artery vessel walls, without cutting or permanentlystretching the walls, and without reducing blood flow or increasingblood pressure during operation.

SUMMARY OF THE INVENTION

There are additional features of the invention that will be describedhereinafter and which will form the subject matter of the claimsappended hereto. In this respect, before explaining at least oneembodiment of the invention in detail, it is to be understood that theinvention is not limited in its application to the details ofconstruction and to the arrangements of the components set forth in thefollowing description or illustrated in the drawings. The invention iscapable of other embodiments and of being practiced and carried out invarious ways. Also, it is to be understood that the phraseology andterminology employed herein are for the purpose of the description andshould not be regarded as limiting.

The subject invention discloses a device configured to remove occlusivematerial from a vessel, comprising: a catheter with a hollow elongatedlumen, a proximal opening, and a distal opening; a plaque extractorguide on the distal opening of the catheter, wherein the plaqueextractor guide comprises a substantially cylindrical shape with anexterior surface; wherein the plaque extractor guide comprises a firstchannel traversing subtantially one half of the cylindrical shape, witha proximal opening and a distal opening, wherein the first channel issubstantially crescent shaped, further wherein the plaque extractorguide comprises a second channel traversing subtantially the other halfof the cylindrical shape with a proximal opening and a distal opening,wherein the second channel is substantially circular, further whereinthe proximal end of the second channel is substantially aligned with thedistal opening of the catheter; wherein the distal end of the secondchannel of the plaque extractor guide comprises a slot and a scoop,wherein the scoop comprises a substantially smooth, curved surfaceextending outward, and a distal blunt edge, and the slot comprises asubstantially smooth, curved surface extending inward; a substantiallycylindrical cutting auger contained with the second channel of theplaque extractor guide, wherein the cutting auger comprises a proximalend and a distal end, wherein the proximal end of the cutting auger issubstantially aligned with the distal opening of the catheter; at leasttwo occlusive material cutting edges on a distal end of the cuttingauger extending outwardly from the distal opening of the second channelof the plaque extractor guide; wherein the plaque extractor guide andthe cutting auger are configured to each independently rotate inopposite directions during plaque extraction and move axially inside thevessel to engage the occlusive material; wherein the plaque extractorguide rotates around its center axis, and the cutting auger and catheterrotate in an eccentric rotation and move axially in an eccentric pathwithin the vessel; wherein the slot and the scoop of the plaqueextractor guide shaves and scoops the occlusive material located outsidethe eccentric path of the eccentrically rotating cutter into the sidecutting edges of the cutting auger for emulsification into reducedparticles such that the movement of the slot and the scoop of the plaqueextractor guide does not pierce or cut the vessel wall; whereinocclusive material located within the eccentric path of theeccentrically rotating cutter is emulsified into reduced particles bythe distal cutting edges; wherein the cutting auger is configured to notcontact the vessel wall; wherein the mixture of emulsified occlusivematerial and blood flows in a proximal direction into the catheter lumenthrough the cutting auger; and wherein the remainder of the bloodflowing distally through the substantially crescent shaped first channelof the plaque extractor guide, continues to flow downstream.

The subject invention discloses a device configured to remove occlusivematerial from a vessel, comprising: a catheter with a hollow elongatedlumen, a proximal opening, and a distal opening; a plaque extractorguide on the distal opening of the catheter, wherein the plaqueextractor guide comprises a substantially cylindrical shape with anexterior surface; wherein the plaque extractor guide comprises a firstinternal channel with a proximal opening and a distal opening; furtherwherein the plaque extractor guide comprises a second internal channelwith a proximal opening and a distal opening, wherein the proximal endof the second channel is substantially aligned with the distal openingof the catheter; wherein the distal end of the second channel of theplaque extractor guide comprises a slot and a scoop, wherein the scoopcomprises a substantially smooth, curved surface extending outward, anda distal blunt edge, and the slot comprises a substantially smooth,curved surface extending inward; a substantially cylindrical cuttingauger contained within the second channel of the plaque extractor guide,wherein the cutting auger comprises a proximal end and a distal end,wherein the proximal end of the cutting auger is substantially alignedwith the distal opening of the catheter; at least two occlusive materialcutting edges on the distal end of the cutting auger extending outwardlyfrom the distal opening of the second channel of the plaque extractorguide; wherein the plaque extractor guide and the cutting auger areconfigured to each independently rotate in opposite directions duringplaque extraction and move axially inside the vessel to engage theocclusive material; wherein the plaque extractor guide rotates aroundits center axis, and the cutting auger and catheter rotate in aneccentric rotation and move axially in an eccentric path within thevessel; wherein the slot and the scoop of the plaque extractor guideshaves and scoops the occlusive material located outside the eccentricpath of the eccentrically rotating cutter into the side cutting edges ofthe cutting auger for emulsification into reduced particles such thatthe movement of the slot and the scoop of the plaque extractor guidedoes not pierce or cut the vessel wall; wherein occlusive materiallocated within the eccentric path of the eccentrically rotating cutteris emulsified into reduced particles by the distal cutting edges;wherein the cutting auger is configured to not contact the vessel wall;wherein the mixture of emulsified occlusive material and blood flows ina proximal direction into the catheter lumen through the cutting auger;and wherein the remainder of the blood flowing distally through thesubstantially crescent shaped first channel of the plaque extractorguide, continues to flow downstream.

The subject invention further discloses a device configured to removeocclusive plaque from a vessel, comprising: a catheter with a hollowelongated lumen, a proximal opening, and a distal opening; a plaqueextractor shield on the distal opening of the catheter, wherein theplaque extractor shield comprises a substantially cylindrical shape withan exterior surface; wherein the plaque extractor shield comprises afirst channel traversing subtantially one half of the cylindrical shape,with a proximal opening and a distal opening, wherein the first channelis substantially crescentoid shaped, further wherein the plaqueextractor shield comprises a second channel traversing subtantially theother half of the cylindrical shape with a proximal opening and a distalopening, wherein the second channel is substantially circular, furtherwherein the proximal end of the second channel is substantially alignedwith the distal opening of the catheter; wherein the distal end of thesecond channel of the plaque extractor shield comprises a slot and ascoop, wherein the scoop comprises a substantially smooth, curvedsurface extending outward, and a distal blunt edge, and the slotcomprises a substantially smooth, curved surface extending inward; asubstantially cylindrical plaque emulsifier contained within the secondchannel of the plaque extractor shield, wherein the plaque emulsifiercomprises a proximal end and a distal end, wherein the proximal end ofthe plaque emulsifier is substantially aligned with the distal openingof the catheter; at least two occlusive plaque cutting edges on thedistal end of the plaque emulsifier extending outwardly from the distalopening of the second channel of the plaque extractor shield; whereinthe plaque extractor shield and the plaque emulsifier are configured toeach independently rotate in opposite directions during plaqueextraction and move axially inside the vessel to engage the occlusiveplaque; wherein the plaque extractor shield rotates around its centeraxis, and the plaque emulsifier and catheter rotate in an eccentricrotation and move axially in an eccentric path within the vessel;wherein the slot and the scoop of the plaque extractor shield shaves andscoops the occlusive plaque located outside the eccentric path of theeccentrically rotating cutter into the side cutting edges of the plaqueemulsifier for emulsification into reduced particles such that themovement of the slot and the scoop of the plaque extractor shield doesnot pierce or cut the vessel wall; wherein occlusive plaque locatedwithin the eccentric path of the eccentrically rotating cutter isemulsified into reduced particles by the distal cutting edges; whereinthe plaque emulsifier is configured to not contact the vessel wall;wherein the mixture of emulsified occlusive plaque and blood flows in aproximal direction into the catheter lumen through plaque emulsifier;and wherein the remainder of the blood flowing distally through thesubstantially crescent shaped first channel of the plaque extractorguide, continues to flow downstream.

In embodiments of the subject invention, the plaque extractor guiderotates at a rate of 20 rpm to 180 rpm.

In embodiments of the subject invention, the cutting auger rotates at arate of 60 rpm to 5000 rpm.

In embodiments of the subject invention, the distal remaining blood flowthrough the first channel of the plaque extractor guide substantiallymaintains internal blood pressure within the vessel.

In embodiments of the subject invention, the distal remaining blood flowthrough the first channel of the plaque extractor guide substantiallyreduces any increase in internal blood pressure within the vessel due toinsertion and operation of the device within the vessel.

In embodiments of the subject invention, the plaque extractor guidecomprises a diameter of 1.5 to 8 millimeters.

In embodiments of the subject invention, the rotational movement of theplaque extractor guide is independent from the rotational movement ofthe screw cutter, wherein the plaque extractor guide and the screwcutter are locked to maintain the same relative axial positions to oneanother.

In embodiments of the subject invention, the cutting auger rotates at arate faster than the plaque extractor guide.

In embodiments of the subject invention, the substantially crescentshaped first channel comprises a width of 30% to 45% of the diameter ofthe plaque extractor guide.

In embodiments of the subject invention, the substantially circularshaped second channel comprises a width of 30% to greater than 50% ofthe diameter of the plaque extractor guide.

In embodiments of the subject invention, the plaque extractor guide andthe cutting auger are configured to each independently rotate in thesame direction during navigation to move axially within a guide sheath,guide catheter or blood vessel while the device is being delivered tothe occlusion site to minimize friction against the sheath, catheter andvessel walls.

In embodiments of the subject invention, the substantially circularshaped second channel comprises a diameter that is 50% to 150% largerthan width of the substantially crescent shaped first channel on theplaque extractor guide.

In embodiments of the subject invention, the plaque extractor guide mayalso be referred to as a plaque extractor shield, plaque extractorguard, plaque extractor cover, plaque extractor scoop or other termsknown to those skilled in the art.

In embodiments of the subject invention, the first channel of the plaqueextractor guide may be substantially crescent shaped, crescentoidshaped, c-shaped, oval, circular, half-moon shaped, sickle shaped,menicus shaped, or other shapes known to those skilled in the art.

In embodiments of the subject invention, the cutting auger may also bereferred to as an extraction wire, a screw auger, plaque extractor,plaque emulsifier, plaque macerator, plaque pulverizer, plaqueseparator, plaque remover, or other terms known to those skilled in theart.

In additional embodiments of the subject invention, the first crescentshaped channel may comprise an inflatable and deflatable balloon. Inthis embodiment, as the plaque extractor guide and cutting auger arebeing delivered to or removed from the occlusion material site, theballoon structure is deflated to minimize the overall diameter of theplaque extractor guide and allow a smaller incision on the patient andsmaller diameter guide sheath or guide catheter to be used to access theoccluded vessel.

In embodiments of the subject invention, the balloon structure may beinflated during plaque extraction and deflated during delivery andremoval of the device to minimize the overall diameter of the extractorguide, allowing the use of a smaller diameter guide catheter to accessthe occluded vessel.

In embodiments of the subject invention, the cutting auger may beconstructed with or without a lumen passing axially through its centeraxis, allowing the device to be delivered over a guide wire whereapplicable.

In embodiments of the subject invention, the term “substantially” isdefined as at least close to (and can include) a given value or state,as understood by a person of ordinary skill in the art. In oneembodiment, the term “substantially” refers to ranges within 10%,preferably within 5%, more preferably within 1%, and most preferablywithin 0.1% of the given value or state being specified.

In embodiments of the subject invention, the term “relatively” isdefined as a comparison of a property, or the proportion of a propertybetween two components.

BRIEF DESCRIPTION OF THE DRAWINGS

Advantages of the present invention will be apparent from the followingdetailed description of embodiments, which description should beconsidered in conjunction with the accompanying drawings, in which:

FIG. 1 Illustrates a top isometric view of a plaque extractor with aplaque extractor guide, a cutting auger, and a catheter.

FIG. 2 Illustrates a front view of a distal end of the plaque extractorwith the guide, the cutting auger, and the catheter.

FIG. 3 Illustrates a side view of the distal end of the plaque extractorwith the guide and the cutting auger.

FIG. 4 Illustrates another top isometric view of the distal end of theplaque extractor with the guide and the cutting auger.

FIG. 5 Illustrates another top isometric view of the distal end of theplaque extractor with the guide and the cutting auger.

FIG. 6 Illustrates a side cross-sectional view of the distal end of theplaque extractor with the guide and the cutting auger.

FIG. 7 Illustrates a side cross-sectional view of the distal end of theplaque extractor with the guide and the cutting auger within a vessel.

FIG. 8 Illustrates another side cross-sectional view of the distal endof the plaque extractor, with the guide and the cutting auger within avessel, including arrows indicating blood flow.

FIG. 9 Illustrates a top isometric view of the plaque extractor guide,the cutting auger, and the catheter of the subject invention.

FIG. 10 Illustrates a top isometric view of the plaque extractor guidewithout the internal cutting auger.

FIG. 11 Illustrates a front view of the plaque extractor guide withoutthe internal cutting auger.

FIG. 12 Illustrates a side view of the plaque extractor guide withoutthe internal cutting auger.

FIG. 13 Illustrates a side cross-sectional view of the plaque extractorguide without the internal cutting auger.

FIG. 14 Illustrates a top isometric view of the cutting auger.

FIG. 15 Illustrates a front view of the cutting auger.

FIG. 16 Illustrates a side view of the cutting auger.

DETAILED DESCRIPTION OF THE EMBODIMENTS

While several variations of the present invention have been illustratedby way of example in particular embodiments, it is apparent that furtherembodiments could be developed within the spirit and scope of thepresent invention. However, it is to be expressly understood that suchmodifications and adaptations are within the spirit and scope of thepresent invention, and are inclusive, but not limited to the followingappended claims as set forth.

As illustrated in FIGS. 1-16 , the subject invention discloses a plaqueemulsifying, removal, and extraction device 1 for use in minimallyinvasive intravascular plaque removal from the inner walls 10 of bloodvessels 13. The device 1 includes a catheter 2 containing a hollowelongated lumen with a distal end with a substantially cylindricalcutting auger 9 surrounded by a plaque extractor guide 3.

The plaque extractor guide 3 is a substantially cylindrical shape withan exterior surface 11. In other embodiments of the subject invention,the plaque extractor guide 3 may also be referred to as a plaqueextractor shield, plaque extractor guard, plaque extractor cover, plaqueextractor scoop or other terms known to those skilled in the art.

The plaque extractor guide 3 also contains a first channel 4 traversingsubtantially one half of the cylindrical shape, with a proximal openingand a distal opening, wherein the first channel 4 is substantiallycrescent shaped. In embodiments of the subject invention, the firstchannel 4 of the plaque extractor guide 3 may be substantially crescentshaped, crescentoid shaped, c-shaped, oval, circular, half-moon shaped,sickle shaped, menicus shaped, or other shapes known to those skilled inthe art. The substantially crescent shaped first channel 4 may be awidth of 30% to 45% of the diameter of the plaque extractor guide 3.

The plaque extractor guide 3 also includes a second channel 5 traversingsubtantially the other half of the cylindrical shape with a proximalopening and a distal opening. The second channel 5 is substantiallycircular. The proximal end of the second channel 5 is substantiallyaligned with the distal opening of the catheter 2. The distal end of thesecond channel 5 of the plaque extractor guide 3 contains a slot 6 and ascoop 7. The scoop 7 includes a substantially smooth, curved surfaceextending outward, and a distal blunt edge 8. The slot 6 contains asubstantially smooth, curved surface extending inward. The substantiallysmooth surfaces of the exterior surface 11, scoop 7, edge 8, and slot 6of the plaque extractor guide 3 cannot cut or tear the inner walls 10 ofblood vessels 13 during operation of the device 1.

The substantially cylindrical cutting auger 9 contained with the secondchannel 5 of the plaque extractor guide 3, contains a proximal end and adistal end. In embodiments of the subject invention, the cutting auger 9may also be referred to as an extraction wire, a screw auger, plaqueextractor, plaque emulsifier, plaque macerator, plaque pulverizer,plaque separator, plaque remover, or other terms known to those skilledin the art. The proximal end of the cutting auger 9 is substantiallyaligned with the distal opening of the catheter 2. The cutting auger 9contains helical ridges 14, and at least two occlusive material cuttingedges 12 on the distal end, extending outwardly from the distal openingof the second channel 5 of the plaque extractor guide 3. Due to the sizeand configuration of the cutting edges 12, they cannot reach the innerwalls 10 of blood vessels 13 during operation of the device 1,preventing any cutting or tearing of the inner walls 10 of blood vessels13, by the cutting edges 12.

The cutting auger 9 may be implemented with a hole axially through thecenter, for delivery of the plaque extractor 3 over a guide wire, orwith a solid center for applications not requiring a guide wire.

In embodiments of the subject invention, to insert the device 1, a smallincision may be made on the patient, near the blood vessel 13 to betreated, or femoral, brachial, or radial access may be used with thedevice 1 being directed to the occlusion site to be treated using guidesheaths or guide catheters.

During delivery (or navigation) of the device 1 to the occlusion sitethe plaque extractor guide 3 and the cutting auger 9 may be configuredto each independently rotate in the same direction, thereby reducingfriction, to move axially within the guide sheaths, guide catheters, andblood vessels until the occlusion site is reached.

Once the device 1 has reached the occlusion site to be treated, theplaque extractor guide 3 and the cutting auger 9 are configured to eachindependently rotate in opposite directions during plaque extraction andmove axially inside the vessel 13 to engage the occlusive material. Thecutting auger 9 may rotate at a rate equal to, faster, or slower thanthe plaque extractor guide 3. Once in contact with the occlusion, orwhen restricted by the inner diameter of a blood vessel 13, the plaqueextractor guide 3 rotates around its center axis. The plaque extractorguide 3 rotation may be concentric with the inner vessel wall 10.

The cutting auger 9 and catheter 2 rotate in an eccentric rotation withregard to the plaque extractor guide 3 and the inner vessel wall 10. Dueto this eccentric rotation, the cutting auger 9 and catheter 2 moveaxially in an eccentric path within the vessel, substantially coveringthe entire cross-section of the extractor guide 3. The plaque extractorguide 3 and the cutting auger 9 are locked to maintain the same relativeaxial positions to one another.

The slot 6 and the scoop 7 of the plaque extractor guide 3 shaves andscoops the occlusive material located outside the eccentric path of theeccentrically rotating cutter 9 into the side cutting edges 12 of thecutting auger 9 for emulsification into reduced particles. The movementof the slot 6 and the scoop 7 of the plaque extractor guide 3 does notpierce or cut the vessel wall 10. Any occlusive material located withinthe eccentric path of the eccentrically rotating cutter auger 9 isemulsified into reduced particles by the distal cutting edges 12.

During the plaque emulsification process, laminar blood flow 15 withinthe blood vessel 13 is not stopped. Blood continues to flow 15 distallythrough the substantially crescent shaped first channel 4 of the plaqueextractor guide 3. A portion of the blood flows 15 around and into thedevice 1. The mixture of emulsified occlusive material and blood flows15 in a proximal direction into the catheter 2 lumen through the cuttingauger 9, while the remainder of the blood continues to flow 15downstream. This blood flow 15 substantially maintains internal bloodpressure downstream within the vessel and reduces any increase ininternal blood pressure within the vessel due to insertion and operationof the device within the vessel.

In an additional embodiment of the subject invention, the first crescentshaped channel 4 may be accomplished with an inflatable and deflatableballoon structure. In this embodiment, as the plaque extractor guide 3and the cutting auger 9 are being delivered to or removed from theocclusion material site, the balloon structure is deflated to minimizethe overall diameter of the extractor guide 3 and allow a smallerincision on the patient and a smaller diameter guide catheter to be usedto access the occluded vessel.

1. A device configured to remove occlusive material from a vessel,comprising: a catheter with a hollow elongated lumen, a proximalopening, and a distal opening; a plaque extractor guide on the distalopening of the catheter, wherein the plaque extractor guide comprises asubstantially cylindrical shape with an exterior surface; wherein theplaque extractor guide comprises a first channel traversing subtantiallyone half of the cylindrical shape, with a proximal opening and a distalopening, wherein the first channel is substantially crescent shaped,further wherein the plaque extractor guide comprises a second channeltraversing subtantially the other half of the cylindrical shape with aproximal opening and a distal opening, wherein the second channel issubstantially circular, further wherein the proximal end of the secondchannel is substantially aligned with the distal opening of thecatheter; wherein the distal end of the second channel of the plaqueextractor guide comprises a slot and a scoop, wherein the scoopcomprises a substantially smooth, curved surface extending outward, anda distal blunt edge, and the slot comprises a substantially smooth,curved surface extending inward; a substantially cylindrical cuttingauger is contained within the second channel of the plaque extractorguide, wherein the cutting auger comprises a proximal end and a distalend, wherein the proximal end of the cutting auger is substantiallyaligned with the distal opening of the catheter; wherein the helicalshaped edges of the cutting auger are sharp and there are at least twoocclusive material cutting edges on the distal end of the cutting augerextending outwardly from the distal opening of the second channel of theplaque extractor guide; wherein the plaque extractor guide and thecutting auger are configured to each independently rotate in oppositedirections during plaque extraction and move axially inside the vesselto engage the occlusive material; wherein the plaque extractor guide andthe cutting auger are configured to each independently rotate in thesame direction during navigation to move axially within a guide sheath,guide catheter or blood vessel while the device is being delivered tothe occlusive material site to minimize friction against the sheath,catheter and vessel walls; wherein the plaque extractor guide rotatesaround its center axis, and the cutting auger and catherer rotate in aneccentric rotation and move axially in an eccentric path within thevessel; wherein the slot and the scoop of the plaque extractor guideshaves and scoops the occlusive material located outside the eccentricpath of the eccentrically rotating cutter into the side cutting edges ofthe cutting auger for emulsification into reduced particles such thatthe movement of the slot and the scoop of the plaque extractor guidedoes not pierce or cut the vessel wall; wherein occlusive materiallocated within the eccentric path of the eccentrically rotating cutteris emulsified into reduced particles by the distal cutting edges;wherein the cutting auger is configured to not contact the vessel wall;wherein the mixture of emulsified occlusive material and blood flows ina proximal direction into the catheter lumen through the cutting auger;and wherein the remainder of the blood flowing distally through thesubstantially crescent shaped first channel of the plaque extractorguide, continues to flow downstream.
 2. The device of claim 1, whereinthe plaque extractor guide rotates at a rate of 20 rpm to 180 rpm. 3.The device of claim 1, wherein the screw cutter rotates at a rate of 60rpm to 5000 rpm.
 4. The device of claim 1, wherein the distal remainingblood flow through the first channel of the plaque extractor guidesubstantially maintains internal blood pressure within the vessel. 5.The device of claim 1, wherein the distal remaining blood flow throughthe first channel of the plaque extractor guide substantially reducesany increase in internal blood pressure within the vessel due toinsertion and operation of the device within the vessel.
 6. The deviceof claim 1, wherein the plaque extractor guide comprises a diameter of1.5 to 8 millimeters.
 7. The device of claim 1, wherein the rotationalmovement of the plaque extractor guide is independent from therotational movement of the cutting auger, wherein the plaque extractorguide and the cutting auger are locked to maintain the same relativeaxial positions to one another.
 8. The device of claim 1, wherein thecutting auger rotates at a rate faster than the plaque extractor guide.9. The device of claim 1, wherein the substantially crescent shapedfirst channel comprises a width of 30% to 45% of the diameter of theplaque extractor guide.
 10. The device of claim 1, wherein thesubstantially circular shaped second channel comprises a width of 30% togreater than 50% of the diameter of the plaque extractor guide.
 11. Thedevice of claim 1, wherein the substantially circular shaped secondchannel comprises a diameter that is 50% to 150% larger than width ofthe substantially crescent shaped first channel on the plaque extractorguide.
 12. A device configured to remove occlusive material from avessel, comprising: a catheter with a hollow elongated lumen, a proximalopening, and a distal opening; a plaque extractor guide on the distalopening of the catheter, wherein the plaque extractor guide comprises asubstantially cylindrical shape with an exterior surface; wherein theplaque extractor guide comprises a first internal channel with aproximal opening and a distal opening; further wherein the plaqueextractor guide comprises a second channel with a proximal opening and adistal opening, wherein the proximal end of the second channel issubstantially aligned with the distal opening of the catheter; whereinthe distal end of the second channel of the plaque extractor guidecomprises a slot and a scoop, wherein the scoop comprises asubstantially smooth, curved surface extending outward, and a distalblunt edge, and the slot comprises a substantially smooth, curvedsurface extending inward; a substantially cylindrical cutting augercontained with the second channel of the plaque extractor guide, whereinthe cutting auger comprises a proximal end and a distal end, wherein theproximal end of the cutting auger is substantially aligned with thedistal opening of the catheter; wherein the helical shaped edges of thecutting auger are sharp and there are at least two occlusive materialcutting edges on a distal end of the cutting auger extending outwardlyfrom the distal opening of the second channel of the plaque extractorguide; wherein the plaque extractor guide and the cutting auger areconfigured to each independently rotate in opposite directions duringplaque extraction and move axially inside the vessel to engage theocclusive material; wherein the plaque extractor guide and the cuttingauger are configured to each independently rotate in the same directionduring navigation to move axially within a guide sheath, guide catheteror blood vessel while the device is being delivered to the occlusivematerial site to minimize friction against the sheath, catheter andvessel walls; wherein the plaque extractor guide rotates around itscenter axis, and the cutting auger and catherer rotate in an eccentricrotation and move axially in an eccentric path within the vessel;wherein the slot and the scoop of the plaque extractor guide shaves andscoops the occlusive material located outside the eccentric path of theeccentrically rotating cutter into the side cutting edges of the cuttingauger for emulsification into reduced particles such that the movementof the slot and the scoop of the plaque extractor guide does not pierceor cut the vessel wall; wherein occlusive material located within theeccentric path of the eccentrically rotating cutter is emulsified intoreduced particles by the cutting edges; wherein the cutting auger isconfigured to not contact the vessel wall; wherein blood continues toflow distally through the substantially crescent shaped first channel ofthe plaque extractor guide; wherein a portion of the blood flows aroundand into the device: wherein the mixture of emulsified occlusivematerial and blood flows in a proximal direction into the catheter lumenthrough the cutting auger; wherein the remainder of the blood continuesto flow downstream.
 13. The device of claim 12, wherein the plaqueextractor guide rotates at a rate of 20 rpm to 180 rpm.
 14. The deviceof claim 12, wherein the cutting auger rotates at a rate of 60 rpm to5000 rpm.
 15. The device of claim 12, wherein the distal remaining bloodflow through the first channel of the plaque extractor guidesubstantially maintains internal blood pressure within the vessel. 16.The device of claim 12, wherein the distal remaining blood flow throughthe first channel of the plaque extractor guide substantially reducesany increase in internal blood pressure within the vessel due toinsertion and operation of the device within the vessel.
 17. The deviceof claim 12 wherein the plaque extractor guide comprises a diameter of1.5 to 8 millimeters.
 18. The device of claim 12, wherein the rotationalmovement of the plaque extractor guide is independent from therotational movement of the screw cutter, wherein the plaque extractorguide and the cutting auger are locked to maintain the same relativeaxial positions to one another.
 19. The device of claim 12, wherein thecutting auger rotates at a rate faster than the plaque extractor guide.20. The device of claim 12, wherein the substantially crescent shapedfirst channel comprises a width of 30% to 45% of the diameter of theplaque extractor guide.